Vygon Exchange Transfusion Tray 275.00
FDA 510(k) K851477 · Vygon Corp.
510(k) numberK851477
Submission
- Device name
- Vygon Exchange Transfusion Tray 275.00
- Applicant
- Vygon Corp.
East Rutherford, NJ, US - Received
- April 15, 1985
- Decision date
- May 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BRZ – Set, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Vygon Exchange Transfusion Tray 275.00 cleared by the FDA?
Vygon Exchange Transfusion Tray 275.00 (K851477) received a 510(k) decision of Substantially Equivalent on May 3, 1985, 18 days after the submission was received.
What is the product code of K851477?
The FDA product code is BRZ – Set, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.